Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a result, patients suffer from everyday disability, with consequences on their occupational activities and social contact, sometimes severely altering their quality of life. To date, no anti-fibrosis treatment has proven effective; existing vasodilation treatments are unfortunately not very effective, and are associated with adverse effects or restrictions. It is consequently of utmost importance that an effective treatment for sclerodermic hands be developed. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc. The injection of SVF into the fingers would also make it possible to control the production of the extracellular matrix and to improve the balance between fibrosis and fibrolysis, resulting in an improvement of cutaneous sclerosis The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison to the control group.
NCT02866552 — Systemic Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/systemic-sclerosis/NCT02866552/
Duke Scleroderma Clinic Patient Registry
The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about scleroderma. This information could be used in future research to increase the understanding of disease mechanisms, treatments, and outcomes. This research may also help develop new therapies, novel measures of disease assessment or identify previously unknown manifestations of the diseases. A prospectively followed cohort is an integral component of future translational and clinical research programs. A registry for scleroderma would allow for information to be gleaned about patients in "real-world situations" in an effort to improve the reality, generalizability and applicability of information gathered.
NCT02851875 — Systemic Sclerosis
Status: Terminated
http://inclinicaltrials.com/systemic-sclerosis/NCT02851875/
Novel Rehabilitation Strategies to Improve Arm Function in Patients With Scleroderma
The purpose of this study is to determine the feasibility and preliminary effects of a novel treatment approach to improve arm function in patients with scleroderma who have upper extremity contractures. It is a Phase 1, one arm trial in which participants will be assessed at baseline, 4 weeks, and 8 weeks. The rehabilitation intervention will involve 8 individual sessions with an occupational therapist. Feasibility of the procedures is a major focus of this project.
NCT02837549 — Scleroderma
Status: Completed
http://inclinicaltrials.com/scleroderma/NCT02837549/
Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients sclérodemiques. Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional. we see patient data analysis with systemic sclerosis who used cardiac transplantation to understand the primitive cardiac damage associated with systemic sclerosis
NCT02808481 — Systemic Sclerosis
Status: Not yet recruiting
http://inclinicaltrials.com/systemic-sclerosis/NCT02808481/
Assessing and Comparing the Effect of Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers.
Digital ulcers are one of the most prevalent complications of scleroderma (systemic sclerosis). There can be found few surveys on effect of topical agents on healing process of the ulcers. Thus, the aim of this study is to assess and compare the effects of topical diltiazem on SSc digital ulcers versus topical nitroglycerin.
NCT02801305 — Digital Ulcer of Scleroderma
Status: Completed
http://inclinicaltrials.com/digital-ulcer-of-scleroderma/NCT02801305/
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.
NCT02740569 — Sleep Apnea, Obstructive
Status: Completed
http://inclinicaltrials.com/sleep-apnea-obstructive/NCT02740569/
A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
NCT02597933 — Scleroderma, Systemic
Status: Completed
http://inclinicaltrials.com/scleroderma-systemic/NCT02597933/
Light-based Therapy as a Novel Treatment for Digital Ulcers in Patients With Systemic Sclerosis
Digital (finger) ulcers are common in patients with systemic sclerosis (SSc) and causes much pain and affects how patients use their hands. Our current treatments for digital ulcers are often not effective and have may have significant side effects (because they increase blood flow to the ulcer to try and help healing). Light-based treatment has been successfully used to treat chronic diabetic, pressure and venous ulcers. The investigators wish to investigate whether light-based treatment is a safe and effective treatment for digital ulcers in patients with SSc.
NCT02472743 — Scleroderma, Systemic
Status: Completed
http://inclinicaltrials.com/scleroderma-systemic/NCT02472743/
Safety & Suitability of Dabigatran to Inhibit Thrombin in Scleroderma
This study evaluates if dabigatran etexilate is safe for use in patients with Scleroderma and Interstitial Lung Disease. All patients will receive 75mg of dabigatran etexilate twice a day for 6 months.
NCT02426229 — Interstitial Lung Disease
Status: Completed
http://inclinicaltrials.com/interstitial-lung-disease/NCT02426229/
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
NCT02396238 — Systemic Sclerosis
Status: Completed
http://inclinicaltrials.com/systemic-sclerosis/NCT02396238/